Silent Aspiration Following Extubation in the ICU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fiberoptic Endoscopic Evaluation of Swallowing (FEES).
- Who it may be relevant to
- Registry conditions: Silent Aspiration, Post-Extubation Dysphagia, Deglutition Disorders, Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Incidence, Risk Factors, and Outcomes of Silent Aspiration Post Extubation in the ICU
Overview
Post-extubation dysphagia is common in critically ill patients and may lead to silent aspiration, which often remains undetected because patients do not exhibit overt clinical signs such as coughing or choking. Current bedside nursing swallow screening may fail to identify silent aspiration in patients recovering from prolonged mechanical ventilation. The goal of this observational study is to learn about the incidence, risk factors, and clinical outcomes of silent aspiration in critically ill adult patients who require prolonged mechanical ventilation and are extubated in the ICU. The main questions it aims to answer are: * How often does silent aspiration occur in ICU patients intubated for 5 days or longer after extubation? * Can silent aspiration be present despite passing the routine bedside nursing swallow screen? * What clinical factors are associated with silent aspiration? * Is silent aspiration associated with worse clinical outcomes such as aspiration pneumonia, reintubation, prolonged ICU stay, ventilator-free days, or mortality? Participants who have been mechanically ventilated for 5 days or more will undergo routine bedside swallow screening followed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES), considered the gold-standard diagnostic tool for detecting silent aspiration, within 72 hours after extubation. Researchers will compare bedside nursing swallow screening results with FEES findings to evaluate the diagnostic accuracy of bedside screening in detecting silent aspiration. Clinical data, swallowing assessment findings, and patient outcomes will also be collected and analyzed.
Detailed description
Background:
Post-extubation dysphagia (PED) is common in critically ill patients and is often multifactorial in origin, resulting from trauma, neuromuscular weakness, altered sensation, impaired cognition, and desynchronized breathing-swallowing coordination. Silent aspiration - defined as entry of oropharyngeal material below the vocal folds without overt clinical signs such as coughing or choking - has been reported in up to 69.3% of ICU patients undergoing instrumental assessment. Despite this, current clinical practice at many centers does not mandate instrumental swallow evaluation for patients who pass routine bedside nursing swallow screening.
Study Design:
This is a prospective observational study conducted in the ICU at Cleveland Clinic Abu Dhabi (CCAD). Informed consent will be obtained from all patients or their next of kin prior to enrollment.
Participants:
Adult ICU patients who have been mechanically ventilated for 5 or more days and are subsequently extubated will be eligible for enrollment. Exclusion criteria include: (1) tracheostomy; (2) do-not-reintubate orders; (3) pregnancy; and (4) absence of informed consent.
Procedures:
All enrolled patients will undergo the standard bedside nursing swallow screen per institutional protocol (CCAD PolicyTech). For the purpose of this study, Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be performed in all enrolled patients up to 72 hours of extubation, regardless of bedside screening results. FEES is a well-established, safe, and portable instrumental assessment that allows direct visualization of pharyngeal and laryngeal structures and detection of aspiration, including silent aspiration. FEES will only be performed after approval by the treating attending physician, and patients with contraindications (e.g., high bleeding risk, high oxygen requirements) will be excluded from the procedure.
Assessments:
FEES findings will be reported using standardized validated scales including the Penetration-Aspiration Scale (PAS), Dysphagia Severity Rating Scale (DSRS), Pharyngeal Residue Severity Rating Scale (PRSS), Murray Secretion Scale, and Airway Protection Scale. Clinical data collected will include age, sex, admitting diagnosis, reasons for intubation, duration of mechanical ventilation, oxygen requirements, bedside swallow screen findings, and clinical outcomes including aspiration pneumonia, reintubation, ventilator-free days, ICU and hospital length of stay, and mortality.
Statistical Analysis:
Descriptive statistics will be used to report the incidence of silent aspiration. Diagnostic accuracy (sensitivity, specificity, Cohen's kappa) of bedside nursing screening will be calculated using FEES as the reference standard. Multivariable logistic regression will identify independent predictors of silent aspiration and its association with clinical outcomes. A minimum sample of 274 patients will be recruited (based on an expected 20% incidence, 95% CI, 5% margin of error, 10% loss to follow-up).
Interventions
- Diagnostic test Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
FEES will be performed within 72 hours after extubation to assess swallowing function and detect silent aspiration in ICU patients following prolonged mechanical ventilation.
Primary outcome measures
- Incidence of Silent Aspiration After Extubation [Time frame: Up to 72 hours after extubation]
Secondary outcome measures (10)
- Diagnostic Accuracy of Bedside Swallow Screening [Time frame: Up to 72 hours after extubation]
- Aspiration Pneumonia [Time frame: Up to 30 days after extubation]
- Reintubation [Time frame: Up to 30 days after extubation]
- Ventilator-Free Days [Time frame: 28 days]
- ICU Length of Stay [Time frame: Up to 24 weeks]
- Hospital length of stay [Time frame: Up to 26 weeks]
- ICU Mortality [Time frame: Up to 24 weeks]
- Hospital Mortality [Time frame: Up to 26 weeks]
- Risk Factors Associated With Silent Aspiration [Time frame: Up to 26 weeks]
- Duration of Dysphagia [Time frame: Up to 3 months]
Eligibility criteria
Inclusion criteria
- Adult ICU patients requiring invasive mechanical ventilation for 5 days or longer
- Successful extubation after invasive mechanical ventilation
- Undergoing bedside nursing swallow screening after extubation
- Ability to undergo Fiberoptic Endoscopic Evaluation of Swallowing (FEES) within 72 hours after extubation
- Provision of informed consent by the patient or legally authorized representative
Exclusion criteria
- Presence of tracheostomy
- Do-not-reintubate orders/Allow natural death
- Pregnancy
- Absence of informed consent
- Contraindication to FEES as determined by the treating physician (e.g., high bleeding risk or severe oxygen requirements)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Arab Emirates · 1 center
- Cleveland Clinic Abu Dhabi — Abu Dhabi
Identifiers
NCT: NCT07635888 · A-2026-026